Lifestyle Enhancement for ADHD Program

ADHD Clinical Trial

— LEAP  

Official title:

Lifestyle Enhancement for ADHD Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690674
• Other study ID #: STUDY00001046
• Secondary ID: R21AT010041-01
• Status: Completed
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: January 21, 2020

Study information

• Verified date: March 2022
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate if physical activity (PA) can increase in children with Attention Deficit/Hyperactivity Disorder (ADHD) using a modified behavioral management training (BMT) program.

Description:

The purpose of this study is to increase physical activity (PA) in children with ADHD using a novel, family-based intervention that promotes PA within the context of evidence-based behavioral management training (BMT) for parents, enhanced with mobile health (mHealth) behavior change strategies. Our first aim is to test the feasibility and acceptability, of an 8-week, family-based, multi-level intervention (BMT-Health) to promote PA in young children with ADHD. Our second aim is to derive an estimate of the effect size of the intervention on PA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 21, 2020
• Est. primary completion date: December 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

Inclusion Criteria:

• age 5-10 years
• ADHD diagnosis
• CGI-S rating >4 and <7
• Per caregiver report, engage in <60 min/day of MVPA for at least 5 days per week
• One adult caregiver willing to participate in the study and complete baseline/follow-up measures
• Caregiver able to complete forms in English
• Caregiver owns a smart phone or similar Garmin compatible mobile device (e.g. iPod Touch) or willing to borrow iPod from study coordinators during the study period
• Agree to install and share data from the Garmin smart phone app with investigators

Exclusion Criteria:

• younger than 5 years old or older than 10 years old
• do not meet criteria for ADHD diagnosis
• Meet diagnostic criteria for psychiatric co-morbidities including Autism Spectrum Disorder, Depressive Disorder, Mood Disorder, Psychotic Disorder, or Intellectual Disability that could interfere with intervention uptake
• Per caregiver report, engage in >60 min/day of MVPA for at least 5 days per week

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• Lifestyle Enhancement for ADHD Program
The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.

Locations

Country	Name	City	State
United States	Seattle Children's Research Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Moderate to Vigorous Physical Activity (MVPA)	Measured by accelerometer worn by participating children	Baseline (measured prior to week 1 of Treatment Group) and week 9
Primary	Garmin Wear Time	The length of time (in days) each participant wore the Garmin device as a measure of feasibility	Weeks 1 - 9
Primary	Number of Facebook Posts	The amount of contribution to the Facebook page (comments, likes, etc) by each participant is a measure of feasibility	Weeks 1 - 9
Primary	Number of Caregivers With Attendance at the Focus Group	Attendance will be taken at the focus group as a measure of study acceptability	Week 9
Secondary	Stop Signal Reaction Time (SSRT) Task Score	Measure of executive function completed by the child. Score is time in ms for participant to respond. Lower score is better.	Baseline to week 9
Secondary	Digit Span (DS) Task - Total Score	Measure of executive function completed by the child. Digit Span Task. Minimum score: 0; Maximum score: 54. Higher score is better outcome.	Baseline to week 9
Secondary	Finger Windows (FW) Task	Measure of executive function completed by the child	Change between baseline and week 9
Secondary	Behavior Rating Inventory of Executive Function (BRIEF)	Measure of executive function completed by the parent. Parent rates whether the child displays each behavior never, sometimes, or often. Global Executive Composite Score: Minimum 35; Maximum 90. Higher score indicates better outcome.	Change between baseline and week 9
Secondary	Impairment Rating Scale (IRS)	Measure of functional impairment completed by the parent. The rating scale measures from 0 to 7, where 0 equals no problem and 7 equals extreme problem. Outcome provided as mean of total raw score. Minimum: 0; Maximum: 100. Higher number indicates higher impairment.	Change between baseline and week 9
Secondary	Alabama Parenting Questionnaire (APQ)	Measure of parenting completed by the parent. The responses are on a 1-5 scale, 1 equals never and 5 equals always. Outcome provided as total raw score. Minimum: 9; Maximum: 45.Higher number indicates better outcome.	Change between baseline and week 9
Secondary	Health Behaviors Survey	Measure of physical activity, sleep, media use, medication use and complementary/alternative medicine use. Measure reported is the number of Caregivers responding 'yes' to item.	Baseline and week 9
Secondary	Child's Sleep Habits Questionnaire (Pre-school and School-aged Children)	The Child's Sleep Habits Questionnaire (pre-school and school-aged children) is a measure of sleep problems completed by the parent. The parent rates each behavior based on their frequency: 'Usually' if something occurs 5 or more times in a week, 'Sometimes' if it occurs 2-4 times in a week, or 'rarely' if something occurs never or 1 times during a week. Parents can also indicate whether or not a sleep habit is a problem by choosing Yes, No, or Not applicable. Total score provided is the sum of all 33 items. Item units are on a scale of 1 -3 points. The Total score range is 33 - 99. The higher the number, the more sleep problems are indicated for the child.	Baseline and week 9
Secondary	Conners-3 Questionnaire	Measure of ADHD symptoms reported by the parent. The scale ranges from 0 to 3 with 0 equaling not true at all and 3 equaling very much true. The Conners t-score range from 0 - 100. The higher the number, the worse the outcome.	Change between baseline and week 9
Secondary	Teacher Vanderbilt	Pre and Post measures of ADHD symptoms reported by the teacher. The measure items' scale ranges from 0 to 3, with 0 equaling never and 3 equaling very often. The Inattention outcome measure reported is the average number of items (symptoms) in the Inattention Sub-scale of the Vanderbilt that teachers rated their students as 2 or higher on the 0-3 scale. There are 9 items in the Inattention sub-scale, and the range of Inattention Symptoms reported by the teacher is 0-9. The Hyperactive/Impulsive outcome measure reported is the average number of items (symptoms) in the Hyperactive/Impulsive Sub-scale of the Vanderbilt that teachers rated their students as 2 or higher on the 0-3 scale. There are 9 items in the Hyperactive/Impulsive sub-scale, and the range of Hyperactive/Impulsive Symptoms reported by the teacher is 0-9.The higher the number, the more symptoms teachers are reporting.	Baseline and week 9